To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD

Last updated: February 11, 2025
Sponsor: Neudive Inc.
Overall Status: Completed

Phase

N/A

Condition

Communication Disorders

Autism

Asperger's Disorder

Treatment

NDTx-01

TAU

Clinical Study ID

NCT06446193
ND-02
RS-2023-00265178
B0081112000610
  • Ages 10-18
  • All Genders

Study Summary

The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children and adolescents between the ages of 10 and 18

  • Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD)based on the clinical judgment of a psychiatrist according to DSM-5 diagnosticcriteria

  • Participants who are able to install 'NDTx-01' on an Android smartphone and use italone or with the help of their guardian

  • Participants who are able to comply with the recommended application time for theinvestigational medical device (6 weeks, 30 times, 5 times a week)

  • Participants who have agreed not to use any other medical devices besides theinvestigational medical device during the clinical trial

  • Participants who agree that there should be no change in the use of drugs which cansignificantly affect one's sociality during the clinical trial (If there is a drugbeing taken during screening, it can be taken continuously, but the total dailydose, ingredients, etc., should remain unchanged until the end of the study visit.)

  • Participants who agree not to participate in other Applied Behavior Analysis (ABA)treatment/rehabilitation/education, social treatment/rehabilitation/educationprogram (If there is treatment/rehabilitation/education being received duringscreening, it can be received continuously, but the number of applications andtreatment methods should remain unchanged until the end of the study visit.)

  • Participants who and whose parents (legal guardians) have volunteered to participatein this clinical trial and have given written consent to the subject description andconsent form

  • Participants willing to comply with the clinical trial procedures

Exclusion

Exclusion Criteria:

  • A risk of clinically significant behavioral problems, emotion regulation problems,psychotic symptoms, self-harm, or other harm at a level that affects the treatmentprocess

  • Severe acute/chronic medical or mental illness

  • Serious trauma or surgery performed within 4 weeks before the screening date

  • Participants with other disabilities such as severe neurological diseases (e.g.brain lesions, mental disorders, etc.)

  • Participants who are currently participating in another clinical trial or haveparticipated in another clinical trial within 30 days before the screening date

  • Participants with a previous history of using NDTx-01, the investigational device

  • Participants who have a change in the usage or dosage of drugs which cansignificantly affect one's sociality, or a change in participation intreatment/rehabilitation/education programs that can significantly affect one'ssociality within 8 weeks before the baseline date of the clinical trial

  • In other cases where the investigator determines that participation in the clinicaltrial is inappropriate due to ethical reasons or the possibility of influencing theresults of the clinical trial

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: NDTx-01
Phase:
Study Start date:
August 14, 2024
Estimated Completion Date:
February 06, 2025

Study Description

This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.

The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.

Connect with a study center

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do 50612
    Korea, Republic of

    Site Not Available

  • Daegu Catholic University Medical Center

    Daegu, 42472
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

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